[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470223":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":49,"collaborators":32,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":32,"enrollmentInfo":61,"targetDuration":32,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":32,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"pregnant woman - tenofovir","OTHER","Participants will be started on tenofovir disoproxil fumarate (TDF) 245 mg one tablet per day from week 28 of pregnancy until 6 weeks postpartum.",[13],"Drug: Fumarate, Tenofovir Disoproxil",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Fumarate, Tenofovir Disoproxil","all participants receive the intervention",[9],[21],"TDF",[23],{"name":24,"affiliation":25,"role":26},"Jean-Pierre ADOUKARA, MD","Hôpital de Tokombéré","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Maaga DOURWE, MD","CONTACT","0697073424",null,"dourwemaaga2@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":32,"zip":32,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hôpital Privé de Tokombéré","RECRUITING","Tokonbéré","Cameroon","CM",{"type":42,"coordinates":43},"Point",[44,45],14.14952,10.86727,{"lat":45,"lon":44},[48],{"name":29,"role":30,"phone":32,"phoneExt":32,"email":32},{"type":50,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100470223","phase-4-efficacy-of-tenofovir-disoproxil-on-mother-to-child-transmission-of-hbv-in-tokombr-cameroon-in-pregnant-women-100470223",false,"NCT05403047","Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women","Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth","TOPCHIB","Inclusion criteria:\n\n* Pregnant women with a term of less than 24 weeks of amenorrhea;\n* HBsAg positive ;\n* HBeAg positive or HBeAg negative with a high viral load ( \\> 200 000 UI\u002Fml) ;\n* 16 years old or more on the inclusion day ;\n* Signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent\u002Fadult husband\u002F legal tutor will be collected) which also includes consent for the children\n\nExclusion criteria :\n\n* HIV co-infection;\n* Women treated for HBV;\n* Creatinine clearance \\\u003C30 ml \u002F min;\n* Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);\n* Disease or treatment contraindicating the taking of TDF.","FEMALE","16 Years",{"count":62,"type":63},150,"ESTIMATED","INTERVENTIONAL",[66],"PHASE4","Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation.\n\nThe investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).",[69],"Hepatitis B Virus - Chronic Active","2026-06-25",{"date":72,"type":73},"2026-06-29","ACTUAL",{"date":75,"type":73},"2023-08-22",{"date":77,"type":63},"2028-02",{"name":5,"class":6},1]